The New York Times has an article on the recent decision to loosen regulations on the use of prisoners to test experimental drugs. The article, entitled"Panel Suggests Using Inmates in Drug Trials"and written by Ian Urbina, states:

An influential federal panel of medical advisers has recommended that
the government loosen regulations that severely limit the testing of pharmaceuticals on prison inmates, a practice that was all but stopped three decades ago after revelations of abuse.

The proposed change includes provisions intended to prevent problems
that plagued earlier programs. Nevertheless, it has dredged up a
painful history of medical mistreatment and incited debate among prison
rights advocates and researchers about whether prisoners can truly make
uncoerced decisions, given the environment they live in.

Supporters of such programs cite the possibility of benefit to prison
populations, and the potential for contributing to the greater good.

Until the early 1970’s, about 90 percent of all pharmaceutical products were tested on prison inmates, federal officials
say. But such research diminished sharply in 1974 after revelations of
abuse at prisons like Holmesburg here, where inmates were paid hundreds
of dollars a month to test items as varied as dandruff treatments and
dioxin, and where they were exposed to radioactive, hallucinogenic and
carcinogenic chemicals.

In addition to addressing the abuses at
Holmesburg, the regulations were a reaction to revelations in 1972
surrounding what the government called the Tuskegee Study of Untreated Syphilis
in the Negro Male, which was begun in the 1930’s and lasted 40 years.
In it, several hundred mostly illiterate men with syphilis in rural
Alabama were left untreated, even after a cure was discovered, so that
researchers could study the disease. . . .

Under current regulations, passed in 1978, prisoners can participate
in federally financed biomedical research if the experiment poses no
more than “minimal” risks to the subjects. But a report formally presented to federal officials on Aug. 1 by the Institute of Medicine of the National Academy of Sciences
advised that experiments with greater risks be permitted if they had
the potential to benefit prisoners. As an added precaution, the report
suggested that all studies be subject to an independent review.

“The
current regulations are entirely outdated and restrictive, and
prisoners are being arbitrarily excluded from research that can help
them,” said Ernest D. Prentice, a University of Nebraskagenetics professor and the chairman of a Health and Human Services Departmentcommittee
that requested the study. Mr. Prentice said the regulation revision
process would begin at the committee’s next meeting, on Nov. 2.

The
discussion comes as the biomedical industry is facing a shortage of
testing subjects. In the last two years, several pain medications,
including Vioxx and Bextra, have been pulled off the market because
early testing did not include large enough numbers of patients to catch
dangerous problems.

And the committee’s report comes against
the backdrop of a prison population that has more than quadrupled, to
about 2.3 million, over the last 30 years and that disproportionately
suffers from H.I.V. and hepatitis C, diseases that some researchers say could be better controlled if new research were permitted in prisons. . . .

The Institute of Medicine report was initiated in 2004 when the Health
and Human Services Department asked the institute to look into the
issue. The report said prisoners should be allowed to take part in
federally financed clinical trials so long as the trials were in the
later and less dangerous phase of Food and Drug Administration
approval. It also recommended that at least half the subjects in such
trials be nonprisoners, making it more difficult to test products that
might scare off volunteers. . . .

TalkLeft has some serious concerns about this potential regulatory change and his piece also provides helpful links to the recent federal report "Ethical Considerations of Research Involving Prisoners." Thanks to TalkLeft for pointing me to this article.